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Assistance for Foods for Specific Groups

Regulation (EU) no. 609/2013, become effective on 20 July 2016, has eliminated the class of foodstuffs intended for particular nutritional uses, introducing the class of Foods for Specific Groups (FSG).

In particular, this class of products includes the following subsets of foodstuff, periodically undergoing regulatory updating:

  • infant formulae and follow-on formulae
  • cereal-based foods and other baby foods
  • food for special medical purposes
  • total diet replacement for weight control.

These categories of products are intended for specific population groups with special nutrition requirements.

These include infants and young children, subjects that are vulnerable from a nutritional point of view because of a specific disease, disorder or medical condition, or overweight subjects that should satisfy their essential nutrient need with a low or very low energy content for weight reduction.

The provisions regarding the following are excluded from Regulation (EU) no. 609/2013:

  • gluten-free foods intended for celiac subjects
  • delactosed foods.

The information on the absence or reduced presence of gluten in food can be voluntarily reported in the labelling, in compliance with Regulation (EU) no. 1169/2011. The same applies on the absence or reduced presence of lactose. Moreover, Regulation (EU) no. 828/2014 provides for admitted voluntary information regarding the absence of gluten and/or lactose, or their reduced presence in food.

Based on the provisions of Regulation (EU) no. 609/2013, food intended for sportspeople should also be reclassified: some as food supplements, others as added foods.

As regards food for persons suffering from carbohydrate metabolism disorders (diabetes), this cannot be classified any more as foodstuffs intended for particular nutritional uses. For this category, there are no specific European provisions as a report of the Commission to the European Parliament and to the Council has concluded that there is no scientific evidence to define specific composition criteria for these foods.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for FSG, and can assist companies carrying out the following:

  • check of composition and labelling based on the European and national regulations
  • notification process at the Competent Authority
  • preparation/review of the dossier for foods for special medical purposes.

Thanks to its cooperation with local qualified consultants, Di Renzo Regulatory Affairs can assist companies in the notification not only in Italy but also in other Member States.